Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC

Recruiting

• Conditions: Precancerous Lesion; Colorectal Cancer; Inflammatory Bowel Diseases

• Registration Number: NCT05530746
• Lead Sponsor: Changhai Hospital

Brief Summary

Colorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great importance for preventing CRC. The existing detection methods have high sensitivity for CRC, while limited in colorectal adenoma and IBD. Therefore, exploring a detection method with high sensitivity for colorectal adenoma and IBD is necessary. This project intends to use methylation detection technology, lactic acid modified omics, proteomics, metagenomics, and other omics technology, through the analysis of differences in feces and histological results in healthy volunteers, patients with non-advanced adenoma, patients with advanced adenomas, patients with IBD, and patients with CRC for early screening.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-05
• Last Update Submitted: 2022-09-05
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients whose age is between 18-75.
• Patients who have signed informed consent form.

Exclusion Criteria

• Patients who have undergone colonic resection or polypectomy.
• Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days.
• Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
• Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
• Patients with failed cecal intubation.
• Patients with poor BPQ necessitated a second bowel preparation.
• Patients refusing to participate or to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of advanced colorectal adenoma	Through study completion, an average of 1 year	An advanced colorectal adenoma is defined as a colorectal adenoma ≥10 mm, adenoma with tubulovillous or villous histology, or adenoma with high-grade dysplasia

Secondary Outcome Measures

Name	Time	Method
Detection of colorectal cancer	Through study completion, an average of 1 year	Lesions will be confirmed as malignant by histopathologic examination.
Detection of non-advanced colorectal adenoma	Through study completion, an average of 1 year	A non-advanced colorectal adenoma is defined as tubular adenoma less than 1cm in diameter.

Trial Locations

Locations (1)

Changhai Hospital, Naval Medical University; 🇨🇳 Shanghai, China